BEFORE YOU TAKE LAMIDUS TABLETS. When you must not take it

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1 Lamotrigine Chewable & Dispersible Tablets Consumer Medicine Information WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you take This leaflet answers some common questions about. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found when a medicine has been used for many years. Your doctor has weighed the risks of you taking against the benefits it is expected to have for you. If you have any concerns about using/taking this medicine, ask your doctor or pharmacist. Keep this leaflet with this medicine. You may need to read it again. WHAT TABLET IS USED FOR tablets contain lamotrigine. Lamotrigine belongs to a group of medicines known as antiepileptic medicines. Lamotrigine is used for the treatment of epilepsy in adults and children. It may be used alone or in combination with other antiepileptic medicines. In children, lamotrigine may be used only in combination with other antiepileptic medicines. is used in partial or generalised seizures. It is thought that tablets work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Your doctor may have prescribed tablets for another reason. Ask your doctor if you have any questions about why has been prescribed for you. tablets are not recommended for treatment in children under 2 years of age. There is no evidence that lamotrigine is addictive. tablets may affect your ability to drive a car or operate machinery. BEFORE YOU TAKE TABLETS When you must not take it Do not take tablets if you are allergic to tablets (see Side Effects) or any of the ingredients listed at the end of this leaflet (see Ingredients). Do not take tablets after the expiry date printed on the pack. If you take it after the expiry date has passed, it may not work as well. Do not take if the tablets do not look quite right. Do not take tablets if the packaging is torn or shows signs of tampering. Before you start to take it Tell your doctor if you have any allergies to: any other medicines any other substances, such as foods, preservatives or dyes Tell your doctor if you are pregnant or intend to become pregnant. may affect your unborn baby if you take it during pregnancy but it is still important that you control your fits while you are pregnant. Your doctor will discuss the risks and benefits of taking during pregnancy and help you decide whether or not you should take. It is recommended that women on antiepileptic medicines, such as, receive pre-pregnancy counselling with regard to the risk on their unborn child. Studies have shown a decrease in the levels of folic acid during pregnancy with. It is therefore recommended that you take a folate supplement, e.g. 5 mg folate daily, before becoming pregnant and during the first 12 weeks of your pregnancy. Tell your doctor if you are breastfeeding or planning to breastfeed. is thought to pass into breast milk. Your doctor will discuss the risks and benefits of taking tablets while breast-feeding. Tell your doctor if you have or had any medical conditions, especially the following: you have any liver or kidney problems you have Parkinson s disease, a slowly progressing "movement disorder" with symptoms such as trembling, rigid posture, slow Published by MIMS/myDr May

2 movements and a shuffling, unbalanced walk. may worsen these symptoms. you have a history of allergy or rash to other antiepileptic drugs. If you have not told your doctor about any of the above, tell them before you use Taking other medicines Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may interfere with the absorption or action of These include: Rifampicin (an antibiotic used to treat certain bacterial infections) Phenytoin, sodium valproate, carbamazepine, phenobarbitone, primidone (used to treat epilepsy) Lopinavir/ritonavir (used to treat HIV) Risperidone (used to treat schizophrenia) Felbamate/zonisamide(used to treat seizures) Any form of hormonal contraceptives (eg. oral contraceptive pills) or hormone replacement therapies (HRT) These medicines may be affected by tablets, or may affect how well they work. You may need to use different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist will be able to tell you what to do when taking/being given tablets with other medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking HOW TABLETS ARE GIVEN Using tablets for the first time You may notice that you feel dizzy, tired or unsteady in the first few weeks of treatment with During this period, you may also notice that you have slight problems with your vision. As your reactions may be slower during this period, you should not operate any machinery or appliances and you should not drive a car. If any of these effects do not go away or are troublesome, you should see your doctor. Tell your doctor immediately if you have any suicidal thoughts or mood changes Persons taking antiepileptic medicines, including lamotrigine, may be more likely to think about killing themselves or actually doing so. If you or someone you know demonstrate any of the following warning signs of suicide-related behaviour while taking, contact a healthcare provider immediately, or even go to the nearest hospital for treatment: thoughts or talk of death or suicide, or self-harm or harm to others any recent attempts of self-harm increase in aggressive behaviour, irritability or agitation If you develop any skin rash (e.g. spots or hives) during treatment, contact your doctor immediately. There are reports of skin rash associated with treatment. Some of these may be serious and cause severe illness. If you have any questions about taking tablets, ask your doctor or pharmacist. How much to take Take tablets as directed by your doctor or pharmacist. Never change the dose yourself. Do not increase the dose more quickly than you have been told. Your doctor and pharmacist will be able to tell you: How many tablets to take at each dose How many doses to take each day When to take each of your doses The label on the container that the tablets were supplied in will give the same information. If there is something that you do not understand ask either your doctor or pharmacist. It is usual for the dose of tablets to start at quite a low level and be slowly increased during the first few weeks of treatment. The doses that your doctor prescribes will generally depend on any other antiepileptic medications you are taking for the treatment of epilepsy and your response to Your dose may be different if: You have problems with your liver/kidney(s) You have been taking other antiepileptic medicines which need to be discontinued You are taking hormonal contraceptive pills (oral pills) If you start or stop taking hormonal contraceptives (e.g. the pill) while taking, your doctor may need to adjust the dose of depending on how well your condition is being treated. You should tell your doctor if there are any changes in your menstrual pattern, such as breakthrough bleeding. Your doctor may need to change the dose of during your pregnancy. Published by MIMS/myDr May

3 How to take it tablets may be taken with or without food. tablets can either be swallowed whole with a full glass of water or chewed or dispersed in water (at least enough to cover the whole tablet). When to take it Take your tablets at about the same time each day. Taking your tablets at the same time each day will have the best effect. It will also help you to remember when to take the How long to take it Continue taking tablets until your doctor tells you to stop. Most people will need to take tablets for long periods. If you stop taking tablets your symptoms may return. If you need to discontinue tablets, your doctor would advise you to stop taking tablets only after reducing your daily doses over a period of two weeks. Use in Children is not recommended for treatment of epilepsy in children under 2 years of age. Epilepsy: Children s weight should be checked and the dose reviewed as weight changes occur. If you forget to take it If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking it as you would normally. Do not double a dose to make up for the dose you have missed. If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints. If you take too much (Overdose) Immediately telephone your doctor or the Poisons Information Centre ( ), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much of Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep this telephone number handy. If too many tablets have been taken, it is likely that the following symptoms will be experienced: Rapid, uncontrollable movements of the eyes Unsteadiness when walking Dizziness, headache Clumsiness and lack of coordination Drowsiness Blurred vision Increased seizures/fits/convulsions Loss of consciousness Coma Vomiting WHILE YOU ARE USING TABLETS Your doctor or pharmacist will be able to tell you whether there are any special instructions while you are taking tablets Things you must remember Take tablets exactly as your doctor tells you to. Try not to miss any doses and take the medicine even if you feel well. Visit your doctor regularly for check-ups. Tell all doctors, dentists and pharmacists who are treating you that you are taking If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking If you become pregnant or are trying to become pregnant while taking tablets, tell your doctor immediately. There may be an increased risk of babies developing a cleft lip or cleft palate if tablets are taken during the first few months of pregnancy. Talk to your doctor if you're breast feeding or planning to breast feed. The active ingredient of passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of breastfeeding while you're taking. If you develop any skin rash (e.g. spots or hives) during treatment with tablets, contact your doctor immediately. There are reports of skin rash associated with treatment. Some of these may be serious and cause severe illness. Tell your doctor if you have thoughts of suicide or self-harm at any time during the treatment period. Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Do not take a double dose to make up for the one you have missed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily. Things you must not do Do not give this medicine to anyone else, even if they have the same condition as you. Do not use tablets to treat any other complaints unless your doctor tells you to. Published by MIMS/myDr May

4 Do not stop taking tablets, or lower the dose, without first checking with your doctor. Epilepsy: If you stop taking tablets suddenly, your epilepsy may come back or become worse. This is known as rebound seizures. Your doctor will advise you if you need to stop taking tablets and how. If you are unsure whether you should stop taking tablets talk to your doctor or pharmacist. Things to be careful of Be careful driving or operating machinery until you know how affects you. tablets may make you feel drowsy, dizzy, or cause blurring of vision, which could affect your ability to drive or operate machinery. Make sure you know how to react to tablets before you drive a car, operate machinery, or do anything else that could be dangerous if you are not alert. If this occurs do not drive. If you drink alcohol, the drowsiness, dizziness or lightheadedness may be worse. Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling, dizzy or sleepy. SIDE EFFECTS Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking, even if the problem is not listed below. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Most commonly reported side effects are: Dizziness/unsteadiness Headache Drowsiness Feeling sick (nausea) Vomiting Feeling weak Double vision Blurred vision Tremor Trouble sleeping Loss of memory Confusion Irritability/aggression Agitation Increased activity in children Joint/back pain Other reported side effects include: Diarrhoea Liver problems Tiredness or feeling sleepy Seeing, feeling or hearing things that are not there (hallucination) In general, these side effects usually happen only during the first few weeks of treatment with. If any of these side effects persist, or are troublesome, see your doctor. Ask your doctor or pharmacist any questions you may have. Another rare side effect is Lupuslike reactions which may present as a collection of symptoms consisting of fever, pain in the joints and general ill-health. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following: Thoughts of suicide or self-harm Allergic reactions- symptoms usually include: - Shortness of breath, wheezing, or difficulty breathing - Swelling of the face, lips, tongue or other parts of the body - Rash, itching or hives on the skin Severe skin reactions with blisters, sores or ulceration Fainting High temperature, swelling of the face, enlarged lymph glands in neck/armpits or groin Unusual bleeding or increased tendency to bleed, persistent sore throat and frequent infections and/or anaemia Sore mouth or sore eyes Sudden onset of severe abdominal pain associated with feeling sick (nausea) and being sick (vomiting) Yellowing of skin and whites of eyes with decreased appetite and/or abdominal pain An increase in the frequency of seizures or convulsions Unusual movements that you cannot control such as irregular jerking or shaking of arms and legs Unsteadiness or loss of coordination while walking Worsening of your symptoms if you already have Parkinson s Disease Temporary paralysis or weakness of muscles A very rare side effect is meningitis which may present as a group of symptoms consisting of fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord. These are very serious side effects. You may need urgent medical attention or hospitalisation. All these side effects are very rare. Other side effects not listed above may also occur in some patients. Some of these side effects (for example, changes in your liver function) can only be found when your doctor does tests from time to time to check your progress. Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them. Published by MIMS/myDr May

5 AFTER USING IT Storage Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well. Keep your in a cool, dry place where it stays below 25 C. Keep the tablets dry and protect them from light. Do not store it, or any other medicine, in the bathroom or near a sink. Do not leave it in the car on hot days. Heat and dampness can destroy some medicines. Keep this medicine where young children cannot reach it. Return any unused or expired medicine to your pharmacist Disposal If your doctor tells you to stop taking or you find that they have passed their expiry date, ask your pharmacist what to do with any tablets that are left over. PRODUCT DESCRIPTION What it looks like 25 mg are white to offwhite, uncoated, circular flat beveled tablets debossed with LI2 50 mg are white to offwhite, uncoated, circular flat beveled tablets debossed with LI3 100 mg are white to off-white, uncoated, circular flat beveled tablets debossed with LI4 200 mg are white to off-white, uncoated, circular flat beveled tablets debossed with LI5 Ingredients Active ingredient The active ingredient in tablets is lamotrigine. 25 mg tablets - 25 mg of lamotrigine 50 mg tablets - 50 mg of lamotrigine 100 mg tablets mg of lamotrigine 200 mg tablets mg of lamotrigine Inactive ingredients Microcrystalline cellulose, calcium carbonate, maltodextrin, crospovidone, povidone, Mixed Berries AP0551, aspartame, hyprolose, purified talc, colloidal anhydrous silica, magnesium stearate. Australian Registration numbers 25 mg: AUST R mg: AUST R mg: AUST R mg: AUST R SPONSOR is supplied in Australia by: Ranbaxy Australia Pty Ltd. (A Sun Pharma Company) 9-13 Waterloo Road Macquarie Park NSW 2113 Australia This leaflet was prepared in May Published by MIMS/myDr May